Vitamin D Supplementation and CD4 Count in HIV-Infected Children

The Hospital for Sick Children

Status and phase

Completed

Phase 2

Conditions

HIV

Treatments

Drug: No supplementation

Dietary Supplement: Vitamin D

Study type

Interventional

Funder types

Other

Identifiers

NCT00911664

1000012867

Details and patient eligibility

About

To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care

Full description

The objective of this study is to determine the impact of vitamin D on immunological status in HIV-infected children as measured by CD4 count (CD4 percent). We will determine if vitamin D supplementation leads to a measurable change in CD4 count (CD4 percent) in HIV-infected children in the context of routine clinical care.

Specific study questions are:

Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children?
Do the serum levels of the active form of vitamin D [1, 25(OH)2D and 25(OH)D] correlate with CD4 percent (CD4 count) in HIV-infected children?

Enrollment

54 patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
Age 3 years through 18 years
Voluntary informed consent

Exclusion criteria

Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
Active participation in another treatment trial
Serum calcium < 2mmol/L at baseline